Qvir Kit is a combination of four antiretrovirals. It is prescribed to treat HIV (human immunodeficiency virus) infection. It boosts up the immunity to fight against HIV to manage or treat AIDS (acquired immunodeficiency syndrome).
Qvir Kit restricts the growth of HIV in the body and reduces the risk of getting HIV-related complications to improve the lifespan of an individual. The medicine should be taken with food. Taking these medicines regularly at the same time increases their effectiveness. A dose of this medicine should not be missed as it can affect your recovery. It is important to complete the full course of the treatment until your doctor advises you to stop it.
Some of the common side effects of this medicine are stomach pain, vomiting, nausea, diarrhea, headache, depression, insomnia, taste change, tingling sensation in hands and feet, rashes, etc. These side effects are generally temporary, but if they persist or become serious inform your doctor. This medicine can also make you feel dizzy or drowsy, so it is advised to avoid driving.
Before starting with the treatment, you should consult your doctor if you are pregnant or breastfeeding, or have any health condition. Your doctor may suggest regular laboratory tests to check your blood counts and other bodily functions. If you are HIV positive, you should not breastfeed or share personal belongings like razors or toothbrushes. Consult your doctor to know about safe sex methods to prevent transmission of HIV during intercourse.
USES OF QVIR KIT TABLET :
Atazanavir is an antiretroviral drug .Atazanavir uses include treatment of HIV infection . Ritonavir is an antiretroviral medication used along with other medications to treat HIV/AIDS .
SIDE EFFECTS OF QVIR KIT :
Insomnia (difficulty in sleeping)
Peripheral neuropathy (tingling and numbness of feet and hand)
Increased blood lipid level
Increased liver enzymes
HOW TO USE QVIR KIT
Take this medicine in the dose and duration as advised by your doctor. Check the label before use. Qvir Kit is to be taken with food.
HOW QVIR KIT WORKS
Qvir Kit is a combination of four antiviral medicines: Tenofovir disoproxil fumarate, Emtricitabine, Atazanavir and Ritonavir. Tenofovir disoproxil fumarate and Emtricitabine work by preventing HIV (virus) from multiplying, thereby reducing the amount of virus in your body. They also increase the CD4 cell (white blood cells that protect against infection) count in your blood. Atazanavir and Ritonavir work by interfering with an enzyme (protease), which is required by HIV-infected cells to make new viruses.
SPECIAL PRECAUTIONS FOR QVIR KIT TABLET :
HEPATIC IMPAIRMENT; AVOID USE IN MODERATE TO SEVERE IMPAIRMENT. MAINTAIN ADEQUATE HYDRATION. MONITOR FOR SIGNS OF LIPODYSTROPHY. CAUTION WHEN USED IN PATIENTS WITH DM, HAEMOPHILIA OR HISTORY OF CARDIAC CONDUCTION DISORDERS. DISCONTINUE IF ACUTE HAEMOLYTIC ANAEMIA OCCURS. MAY PROLONG PR INTERVAL ON ECG. REDISTRIBUTION AND ACCUMULATION OF BODY FAT MAY OCCUR. PREGNANCY.
Black Box Warnings
Co-administration of ritonavir with several classes of drugs including sedative hypnotics, anti-arrhythmics or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to the possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir (see contraindications and warnings and precautions sections).
Post Treatment Acute Exacerbation of Hepatitis B
Severe acute exacerbations of hepatitis B have been reported in hbv-infected patients who have discontinued emtricitabine/tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue emtricitabine/tenofovir disoproxil fumarate. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see warnings and precautions).
Each kit contains:
One tablet of Atazanavir and Ritonavir
Atazanavir sulfate IP … 300 mg
Ritonavir IP……………100 mg
One tablet of Tenofovir disoproxil fumarate and Emtricitabine
Tenofovir disoproxil fumarate IP…300 mg
Atazanavir/ritonavir–Oral fixed-dose tablet
Emtricitabine plus Tenofovir disoproxil fumarate-Oral fixed-dose tablet
Each QVIR Kit contains two tablets – one fixed-dose combination tablet of atazanavir/ritonavir and one fixed-dose combination tablet of emtricitabine/tenofovir disoproxil fumarate.
Atazanavir and ritonavir belong to the class of protease inhibitors and act by inhibiting protease enzyme. Emtricitabine and tenofovir disoproxil fumarate belong to the class of nucleoside reverse transcriptase inhibitors and act by inhibiting the reverse transcriptase enzyme.
Atazanavir (ATV) is an azapeptide HIV-1 protease inhibitor (PI). The compound selectively inhibits the virus-specific processing of viral Gag and Gag-Pol polyproteins in HIV-1 infected cells, thus preventing the formation of mature virions.
Concentration- and dose-dependent prolongation of the PR interval in the electrocardiogram (ECG) has been observed in healthy volunteers receiving atazanavir. In a placebo-controlled study (AI424-076), the mean (±SD) maximum change in the PR interval from the pre-dose value was 24 (±15) milliseconds (msec) following oral dosing with 400 mg of atazanavir (n=65) compared to 13 (±11) msec following dosing with placebo (n=67). The PR interval prolongations in this study were asymptomatic. There is limited information on the potential for a pharmacodynamic interaction in humans between atazanavir and other drugs that prolong the PR interval of the ECG (see WARNINGS AND PRECAUTIONS, cardiac conduction Abnormalities).
Electrocardiographic effects of atazanavir were determined in a clinical pharmacology study of 72 healthy subjects. Oral doses of 400 mg (maximum recommended dose) and 800 mg (twice the maximum recommended dosage) were compared with placebo; there was no concentration-dependent effect of atazanavir on the QTc interval (using Fridericia’s correction). In 1793 HIV-infected patients receiving antiretroviral regimens, QTc prolongation was comparable in the atazanavir and comparator regimens. No atazanavir-treated healthy subject or HIV-infected patient had a QTc interval >500 msec (see WARNINGS AND PRECAUTIONS, Cardiac Conduction Abnormalities).
Ritonavir is a peptidomimetic inhibitor of the HIV-1 protease. Inhibition of HIV protease renders the enzyme incapable of processing the gag-pol polyprotein precursor which leads to production of non-infectious immature HIV particles.
Low doses of ritonavir (100 mg) have been used as a pharmacokinetic booster, to boost plasma levels of concomitantly administered protease inhibitors. Boosted protease inhibitors are currently considered the standard of care in HIV therapy.
QTcF interval was evaluated in a randomized, placebo and active controlled (moxifloxacin 400 mg once-daily) crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3. The maximum mean (95% upper confidence bound) time-matched difference in QTcF from placebo after baseline correction was 5.5 (7.6) milliseconds (msec) for 400 mg twice-daily ritonavir. Ritonavir 400 mg twice daily resulted in Day 3 ritonavir exposure that was approximately 1.5 fold higher than observed with ritonavir 600 mg twice-daily dose at steady state.
PR interval prolongation was also noted in subjects receiving ritonavir in the same study on Day 3. The maximum-mean (95% confidence interval) difference from placebo in the PR interval after baseline correction was 22 (25) msec for 400 mg twice-daily ritonavir (see WARNINGS AND PRECAUTIONS, PR Interval Prolongation).
Emtricitabine, a synthetic nucleoside analog of cytidine, is phosphorylated by cellular enzymes to form emtricitabine 5′-triphosphate. Emtricitabine 5′-triphosphate inhibits the activity of the HIV-1 reverse transcriptase (RT) by competing with the natural substrate deoxycytidine 5′-triphosphate and by being incorporated into nascent viral DNA which results in chain termination. Emtricitabine 5′-triphosphate is a weak inhibitor of mammalian DNA polymerase alpha, beta, epsilon and mitochondrial DNA polymerase gamma.
Tenofovir disoproxil fumarate (Tenofovir DF)
Tenofovir disoproxil fumarate is an acyclic nucleoside phosphonate diester analog of adenosine monophosphate. Tenofovir disoproxil fumarate requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylations by cellular enzymes to form tenofovir diphosphate. Tenofovir diphosphate inhibits the activity of HIV-1 reverse transcriptase by competing with the natural substrate deoxyadenosine 5′-triphosphate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of mammalian DNA polymerases alpha , beta, and mitochondrial DNA polymerase gamma.
The pharmacokinetics of atazanavir/ritonavir was evaluated in healthy adult volunteers and in HIV-infected patients after administration of atazanavir 300 mg with ritonavir 100 mg once daily (see Table 1).
Table 1: Steady-state pharmacokinetics of atazanavir/ritonavir in healthy subjects or HIV-infected patients in the fed state
300 mg with ritonavir
100 mg once daily
HIV-infected patients (n=10)
Geometric mean (CV %)